Rx Item-Ala Cort 1% 1% Cream 1 oz By Crown Lab

Clinical Information
Gen. Code and Des.
7544 hydrocortisone TOPICAL CREAM (G) 1 %
GCN and Des.
30942 hydrocortisone TOPICAL CREAM (G) 1 %
Strength
1%
Dose Form
CREAM (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE)
Active Ingredients
2147 hydrocortisone 50237
Inactive Ingredients
2468 propylene glycol 57556
FDA NDA Approved


ALACORT- hydrocortisone cream
Crown Laboratories
For external use only
Not for ophthalmic use
Each gram of ALA-CORT? (Hydrocortisone Cream USP) 1% contains 10 mg hydrocortisone USP in cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.
Each gram of ALA-CORT? (Hydrocortisone Cream USP) 2.5% contains 25 mg hydrocortisone USP in cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
INDICATIONS AND USAGE
Topcial corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
Topcial corticosteroids are contraindicated in those patients with history of hypersensitivity to any of the components of the preparation
DOSAGE AND ADMINISTRATION
Topical corticosteroids are generally applied to the affected area as thin film from two to four times daily depending on the severity of the condition

Rx Item-Ala Cort 1% 1% Cream 1 oz By Cro
RX189163 189163 NDC No. 00316-0126-01 0316-0126-01 00316012601 0031612601 UPC/GTIN No. 3-03160-12601-7 303160-126017 303160126017 MPN No. 00316-0126-01

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Crown Laboratories Inc/Otc RX189163 189163 NDC No. 00316-0126-01 0316-0126-01 00316012601 0031612601 UPC/GTIN No. 3-03160-12601-7 303160-126017 303160126017 MPN No. 00316-0126-01

HYDROCORTISONE TOPICAL CR
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